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A Blood Test to Look at Cells of the Immune System in Healthy Children

Primary Purpose

HIV Infections, HIV Seronegativity

Status
Completed
Phase
Locations
International
Study Type
Observational
Intervention
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for HIV Infections focused on measuring Monocytes, Flow Cytometry, HIV Seronegativity, Phenotype, Lymphocyte Subsets

Eligibility Criteria

1 Day - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria A child may be eligible for this study if he/she: Is 0 - 18 years old. Is HIV-negative and is born to an HIV-negative mother. Is healthy (no serious infection or disease). Has signed informed consent of a parent or legal guardian if under 18. Exclusion Criteria A child will not be eligible for this study if he/she: Is pregnant or breast-feeding. Has already completed this study once before. Is taking prescription medications other than prescription vitamins.

Sites / Locations

  • Univ of Alabama at Birmingham - Pediatric
  • Univ of South Alabama
  • UCSD Med Ctr / Pediatrics / Clinical Sciences
  • Los Angeles County - USC Med Ctr
  • Cedars Sinai / UCLA Med Ctr
  • Harbor - UCLA Med Ctr / UCLA School of Medicine
  • UCSF / Moffitt Hosp - Pediatric
  • Children's Hosp of Washington DC
  • Howard Univ Hosp
  • North Broward Hosp District
  • Univ of Florida Health Science Ctr / Pediatrics
  • Univ of Miami (Pediatric)
  • Palm Beach County Health Dept
  • The Med Ctr Inc
  • Mt Sinai Hosp Med Ctr / Dept of Pediatrics
  • Cook County Hosp
  • Chicago Children's Memorial Hosp
  • Univ of Chicago Children's Hosp
  • Tulane Univ / Charity Hosp of New Orleans
  • Tulane Univ Hosp of New Orleans
  • Johns Hopkins Hosp - Pediatric
  • Children's Hosp of Boston
  • Baystate Med Ctr of Springfield
  • Univ of Massachusetts Med School
  • Univ of Mississippi Med Ctr
  • UMDNJ - Robert Wood Johnson Med School / Pediatrics
  • Univ of Medicine & Dentistry of New Jersey / Univ Hosp
  • Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
  • Children's Hosp at Albany Med Ctr
  • Bronx Lebanon Hosp Ctr
  • Montefiore Med Ctr Adolescent AIDS Program
  • North Shore Univ Hosp
  • Schneider Children's Hosp
  • Bellevue Hosp / New York Univ Med Ctr
  • Harlem Hosp Ctr
  • Univ of Rochester Med Ctr
  • State Univ of New York at Stony Brook
  • Duke Univ Med Ctr
  • Children's Hosp of Philadelphia
  • Med Univ of South Carolina
  • Texas Children's Hosp / Baylor Univ
  • Children's Hospital & Medical Center / Seattle ACTU
  • Ramon Ruiz Arnau Univ Hosp / Pediatrics
  • Univ of Puerto Rico / Univ Children's Hosp AIDS
  • San Juan City Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
July 29, 2008
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00001109
Brief Title
A Blood Test to Look at Cells of the Immune System in Healthy Children
Official Title
Mononuclear Cell Phenotyping in Normal Children
Study Type
Observational

2. Study Status

Record Verification Date
October 2004
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to learn more about some of the immune cells in the blood (CD4 cells, for example) of healthy children in order to better understand the differences in the blood cells of children infected with HIV. Because children's bodies are still developing, their cells are different from those of adults, and their bodies respond differently to infections such as HIV. In order to understand how immune cells grow and mature so that they can fight HIV, it is important to see how these cells behave in normal children.
Detailed Description
Early in life, the cells involved in immune selection differentiate into CD4+ and CD8+ cells. Currently there is insufficient information on the cell maturation and activation of these peripheral blood mononuclear cell (PBMC) subsets in normal children. The critical need for this information has been brought about by the pediatric HIV/AIDS epidemic, which requires the measurement of peripheral blood CD4+ T cells and other cells types for interpretation of HIV disease progression. The immunopathogenesis of pediatric HIV infection differs from that in adults but is not well understood. In order to better understand HIV disease progression in HIV-infected children, these PBMC subsets must be studied in normal children so that control values can be established. Healthy infants, children, and adolescents presenting for routine care or elective surgery have a single blood sample obtained. Blood is used for complete blood count, peripheral blood mononuclear cell flow analysis for surface markers, and plasma and cell storage. Demographic information including age, sex, race, and ethnicity is obtained at the time of the blood draw. The reason for the patient's visit is also documented. No study drugs are administered or supplied as part of this study. Statistical analysis is used to estimate the median distribution of each CD4 and CD8 subset.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, HIV Seronegativity
Keywords
Monocytes, Flow Cytometry, HIV Seronegativity, Phenotype, Lymphocyte Subsets

7. Study Design

Enrollment
630 (false)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria A child may be eligible for this study if he/she: Is 0 - 18 years old. Is HIV-negative and is born to an HIV-negative mother. Is healthy (no serious infection or disease). Has signed informed consent of a parent or legal guardian if under 18. Exclusion Criteria A child will not be eligible for this study if he/she: Is pregnant or breast-feeding. Has already completed this study once before. Is taking prescription medications other than prescription vitamins.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
W Shearer
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
H Rosenblatt
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of Alabama at Birmingham - Pediatric
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Univ of South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
UCSD Med Ctr / Pediatrics / Clinical Sciences
City
La Jolla
State/Province
California
ZIP/Postal Code
920930672
Country
United States
Facility Name
Los Angeles County - USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cedars Sinai / UCLA Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
900481804
Country
United States
Facility Name
Harbor - UCLA Med Ctr / UCLA School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
905022004
Country
United States
Facility Name
UCSF / Moffitt Hosp - Pediatric
City
San Francisco
State/Province
California
ZIP/Postal Code
941430105
Country
United States
Facility Name
Children's Hosp of Washington DC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
200102916
Country
United States
Facility Name
Howard Univ Hosp
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
North Broward Hosp District
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33311
Country
United States
Facility Name
Univ of Florida Health Science Ctr / Pediatrics
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Univ of Miami (Pediatric)
City
Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Palm Beach County Health Dept
City
Riviera Beach
State/Province
Florida
ZIP/Postal Code
33404
Country
United States
Facility Name
The Med Ctr Inc
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31901
Country
United States
Facility Name
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Facility Name
Cook County Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Chicago Children's Memorial Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606143394
Country
United States
Facility Name
Univ of Chicago Children's Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606371470
Country
United States
Facility Name
Tulane Univ / Charity Hosp of New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
701122699
Country
United States
Facility Name
Tulane Univ Hosp of New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
701122699
Country
United States
Facility Name
Johns Hopkins Hosp - Pediatric
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
212874933
Country
United States
Facility Name
Children's Hosp of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
021155724
Country
United States
Facility Name
Baystate Med Ctr of Springfield
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Univ of Massachusetts Med School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
016550001
Country
United States
Facility Name
Univ of Mississippi Med Ctr
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39213
Country
United States
Facility Name
UMDNJ - Robert Wood Johnson Med School / Pediatrics
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
089030019
Country
United States
Facility Name
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
City
Newark
State/Province
New Jersey
ZIP/Postal Code
071032714
Country
United States
Facility Name
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Children's Hosp at Albany Med Ctr
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Bronx Lebanon Hosp Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
Montefiore Med Ctr Adolescent AIDS Program
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
North Shore Univ Hosp
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Schneider Children's Hosp
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Bellevue Hosp / New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Harlem Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
Univ of Rochester Med Ctr
City
Rochester
State/Province
New York
ZIP/Postal Code
146420001
Country
United States
Facility Name
State Univ of New York at Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
117948111
Country
United States
Facility Name
Duke Univ Med Ctr
City
Durham
State/Province
North Carolina
ZIP/Postal Code
277103499
Country
United States
Facility Name
Children's Hosp of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
191044318
Country
United States
Facility Name
Med Univ of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
294253312
Country
United States
Facility Name
Texas Children's Hosp / Baylor Univ
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Children's Hospital & Medical Center / Seattle ACTU
City
Seattle
State/Province
Washington
ZIP/Postal Code
981050371
Country
United States
Facility Name
Ramon Ruiz Arnau Univ Hosp / Pediatrics
City
Bayamon
ZIP/Postal Code
00956
Country
Puerto Rico
Facility Name
Univ of Puerto Rico / Univ Children's Hosp AIDS
City
San Juan
ZIP/Postal Code
009365067
Country
Puerto Rico
Facility Name
San Juan City Hosp
City
San Juan
ZIP/Postal Code
009367344
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
14610491
Citation
Shearer WT, Rosenblatt HM, Gelman RS, Oyomopito R, Plaeger S, Stiehm ER, Wara DW, Douglas SD, Luzuriaga K, McFarland EJ, Yogev R, Rathore MH, Levy W, Graham BL, Spector SA; Pediatric AIDS Clinical Trials Group. Lymphocyte subsets in healthy children from birth through 18 years of age: the Pediatric AIDS Clinical Trials Group P1009 study. J Allergy Clin Immunol. 2003 Nov;112(5):973-80. doi: 10.1016/j.jaci.2003.07.003.
Results Reference
result

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A Blood Test to Look at Cells of the Immune System in Healthy Children

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